Completion of Enrolment and Treatment in the Phase 1 Study of MTX110 in the Treatment of Children with Newly Diagnosed Diffuse Midline Gliomas (DMGs)
10 Luglio 2023 - 2:00PM
10 July 2023
Biodexa Ltd(“Biodexa” or the
“Company”)
Completion of Enrolment and Treatment in
the Phase 1 Study of MTX110 in theTreatment of
Children with Newly Diagnosed Diffuse Midline Gliomas
(DMGs)
Biodexa Ltd (a wholly owned subsidiary of
Biodexa Pharmaceuticals PLC, Nasdaq: BDRX), a clinical stage
biopharmaceutical company developing a pipeline of products aimed
at primary and metastatic cancers of the brain, is pleased to
announce completion of enrolment and treatment of nine paediatric
patients into the ongoing investigator-sponsored Phase I study of
MTX-110 in newly diagnosed DMGs (NCT 04264143).
All of the patients (age range 4-17 years)
were enrolled at the Columbia University Irving Medical Centre and
received radiation therapy as per the institution’s standard of
care. Each patient subsequently underwent surgery with implantation
of an intratumoral catheter and a programmable subcutaneous pump
and 8 out of 9 have received two infusions of MTX110 via
convection-enhanced delivery (CED) separated by a period of 1 week.
Concentrations of 30, 60 or 90 µM were delivered with no
intra-patient dose escalation.
No dose limiting toxicities related to the study
drug have been reported in the study.
Full study results are expected to be made
public around the 1st quarter of 2024.
Commenting, Dr Luca Szalontay, MD,
Assistant Professor of Paediatrics, Columbia University Irving
Medical Centre, said: “We are looking forward to
completing and reporting data from this very important safety study
of MTX110 that has previously demonstrated efficacy in treatment of
patients with DMG. This horrible disease is a very high unmet
medical need as there was no effective treatment established for
patients with DMG and survival remains very poor, at an average of
9-11 months .”
About DMG
DMG is a primary brain tumour arising in the
midline structures of the brain including the pons of the brain
stem, is diffusely infiltrating and cannot be surgically removed.
Occurring mostly in children, the median survival rate in a cohort
of 316 cases was 10.0 months and overall survival at 12 months was
35% (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Although
radiotherapy prolongs survival, the majority of patients die within
one year following diagnosis. Systemic chemotherapy is ineffective,
often due to an inability of agents to cross the blood-brain
barrier. Approximately 1,100 (data on file) individuals are
diagnosed with DIPG worldwide each year.
About MTX110
MTX110 is a water-soluble form of panobinostat
free base, achieved through complexation with
hydroxypropyl-β-cyclodextrin (HPBCD), that enables CED at
potentially therapeutic doses directly to the site of the tumour.
Panobinostat is a hydroxamic acid and acts as a non-selective
histone deacetylase inhibitor (pan-HDAC inhibitor). The currently
available oral formulation of panobinostat lactate (Farydak®) is
not suitable for treatment of brain cancers owing to poor
blood-brain barrier penetration and inadequate brain drug
concentrations. Based on favourable translational science data,
MTX110 is being evaluated clinically as a treatment for recurrent
glioblastoma (NCT05324501), paediatric DMG (NCT04264143) and
recurrent medulloblastoma (NCT04315064). MTX110 is delivered
directly into and around the patient’s tumour via a catheter system
(e.g. CED or fourth ventricle infusions) to bypass the blood-brain
barrier. This technique exposes the tumour to very high drug
concentrations while simultaneously minimising systemic drug levels
and the potential for toxicity and other side effects. Panobinostat
has demonstrated high potency against DIPG and GBM tumour
cells in in vitro and in vivo models, and in a key study it was the
most promising of 83 anticancer agents tested in 14 patient-derived
DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6),
555-559).
This announcement contains inside information
for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR) as
it forms part of UK domestic law by virtue of the European Union
(Withdrawal) Act 2018, as amended.
For more information, please contact:
Biodexa Ltd. |
Dmitry Zamoryakhin, CSO |
Tel: +44 (0)29 20480 180 |
www.biodexapharma.com |
Edison Group (US Investor
Relations) |
Alyssa
Factor |
Tel: +1 (860) 573
9637 |
Email:
afactor@edisongroup.com |
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a
clinical stage biopharmaceutical company developing a pipeline of
products aimed at primary and metastatic cancers of the
brain. The Company’s lead candidate, MTX110, is being studied
in aggressive rare/orphan brain cancer indications including
recurrent glioblastoma and diffuse midline glioma.
MTX110 is a liquid formulation of the histone deacetylase (HDAC)
inhibitor, panobinostat. This proprietary formulation enables
delivery of the product via convection-enhanced delivery (CED) at
potentially therapeutic doses directly to the site of the tumour,
by-passing the blood-brain barrier and avoiding systemic
toxicity.
Biodexa is supported by three proprietary drug delivery
technologies focused on improving the bio-delivery and
bio-distribution of medicines. Biodexa’s headquarters and
R&D facility is in Cardiff, UK. For more information
visit www.biodexapharma.com.
Forward-Looking Statements
Certain statements in this announcement may
constitute “forward-looking statements” within the meaning of
legislation in the United Kingdom and/or United States. Such
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995 and are based on
management’s belief or interpretation. All statements
contained in this announcement that do not relate to matters of
historical fact should be considered forward-looking
statements.
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